Bioequivalence of ciprofloxacin tablet formulations assessed in Indonesian volunteers
Harahap, Y.; Prasaja, B.; Indriati, E.; Lusthom, W.; Lipin
International Journal of Clinical Pharmacology and Therapeutics 45(6): 373-376
2007
ISSN/ISBN: 0946-1965 PMID: 17595895 Document Number: 609251
Aim: Determination of the bioequivalence of two ciprofloxacin tablet formulations (test formulation manufactured by Novell Pharmaceutical Laboratories, Indonesia, reference formulation from Quimica Farmaceutica Bayer, Spain). Subiects and methods: 24 healthy volunteers received each of the two ciprofloxacin formulations at a dose of 500 mg in a 2-way crossover design. Blood samples were obtained prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h after drug administration. Plasma concentrations of ciprofloxacin were monitored using high-perforinance liquid chromatography over a period of 24 h after administration. The pharmacokinetics parameter AUC(0-24h), AUC(0-infinity). and C-max were tested for bioequivalence after I og -transformation of data and ratios of t(max) were evaluated nonparametrically. Results: The point estimates and 90% confidence intervals for AUC(0-24h), AUC(0-infinity). and C-max were 97.55% (92.71 - 102.6%), 97.63 % (92.90 - 102.5 9%) and 95.84% (89.95 - 102. 10%), respectively, satisfying the bioequivalence criteria of the European Committee for Proprietary Medicinal Products and the US Food and Drug Administration guidelines. Conclusion: These results indicate that two medications of ciprofloxacin are bioequivalent and, thus, may be prescribed interchangeably.